Zydus Cadila's ZyCoV-D vaccine gets DCGI nod for emergency use for adults, children above 12 yrs

The Drugs Controller General of India (DCGI) of Friday gave nod to Zydus Cadila's three-dose COVID-19 DNA vaccine for emergency use in adults and children aged 12 years and above, bringing in the sixth vaccine authorized for use in the country.

"The Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today i.e 20/08/2021, the world's first and India's indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including adults and children 12 years and above," a press release of the Department of Biotechnology under the Ministry of Science and Technology read.

"The vaccine is developed in partnership with the Department of Biotechnology, Government of India under the 'Mission COVID Suraksha' and implemented by Biotechnology Industry Research Assistance Council (BIRAC), ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for pre-clinical studies, Phase I and Phase II clinical trials and under the 'Mission COVID Suraksha' and implemented by BIRAC. ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for preclinical studies, Phase I and Phase II clinical trials and under the Mission COVID Suraksha for Phase III clinical trial," it said.

The company said it plans to manufacture 100 million to 120 million doses of ZyCoV-D annually and has started to stockpile the vaccine.

"This three-dose vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring," the statement says.

Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, "It is a matter of great pride that today we have the EUA for the world's first DNA COVID-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. 

The Indian Vaccine Mission COVID Suraksha launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious COVID-19 vaccines for the public health. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development."

Speaking on the development, Chairperson of the Zydus Group, Pankaj R Patel said, "We are extremely happy that our efforts to put out a safe, well-tolerated and efficacious vaccine to fight COVID-19 has become a reality with ZyCoV-D. To create the world's first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation. I'd like to thank the Department of Biotechnology under the Government of India for their support in this mission of Atma Nirbhar Bharat and Indian Vaccine Mission COVID Suraksha."

Union Health Minister Mansukh Mandaviya during monsoon session during the question hour in the Rajya Sabha had said, "The government expects that in October-November, four more Indian pharmaceutical companies will start production of indigenous vaccines that will help to meet the domestic demand. Biological E and Novartis vaccines will also be available in the market in the coming days, while Zydus Cadila will soon get an emergency use nod from Expert Committee."

Zydus Cadila last month had said that it has applied for emergency use authorisation with the Indian Drug regulator for its three-dose COVID-19 vaccine ZyCoV-d, and planned to manufacture 10-12 crore doses annually.

The company has conducted the largest clinical trials for its COVID-19 vaccine in India so far in over 50 centres.

(With agency inputs)